Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presby… (NCT07208604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.
Philippines25 participantsStarted 2025-09-30
Plain-language summary
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 40-65 years
* Healthy cornea
* Refractive error between +4.0 D and -5.0 D
* Phakic or monofocal pseudophakic (≥6 months post IOL placement)
* Visual acuity correctable by ±0.25 D
Exclusion Criteria:
* Corneal dystrophy, scarring, or prior corneal crosslinking
* Astigmatism \>1.0 D
* Active ocular infection, inflammation, or uncontrolled dry eye
* Advanced glaucoma or diabetic retinopathy
* History of delayed corneal healing
* Pregnancy, breastfeeding, or planning pregnancy during study period
* Certain medications (e.g., isotretinoin)
* Recent participation in other investigational drug/device studies (within 30 days)
* Patients with uncontrolled dry eye or surface disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or pursue other presbyopia treatments in the meantime?
2The TECLens procedure uses quantitative refractive crosslinking, which is a relatively new approach for presbyopia — since this is a Phase I study focused on early safety and feasibility, what is currently known about the risks compared to established options like reading glasses, multifocal contact lenses, or LASIK-based corrections?
3The trial's primary goal is to reduce refractive error in presbyopia-aged patients — based on my current prescription and eye health, do you think I would even be a realistic candidate to discuss with the research team once recruitment opens?
4Since this is an open-label study, meaning both the doctors and patients know what treatment is being given, how might that affect how we interpret any improvement I experience in my near vision?
5Are there standard-of-care treatments for presbyopia I should consider first, and if I try one of them now, would that affect my eligibility to participate in this trial later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.